VoirElite 4K 31.5 Surgical Display

GUDID 00860008848925

Surgical Display for Operating Room

Jam-Labs Corp.

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Primary Device ID00860008848925
NIH Device Record Key1bb91051-3d86-4265-a500-3cf7e9f9e23f
Commercial Distribution StatusIn Commercial Distribution
Brand NameVoirElite 4K 31.5 Surgical Display
Version Model NumberJMASM00077/81/82
Company DUNS087271162
Company NameJam-Labs Corp.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860008848925 [Primary]

FDA Product Code

FWCCamera, Television, Surgical, With Audio

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-23
Device Publish Date2024-01-15

Devices Manufactured by Jam-Labs Corp.

00860008848925 - VoirElite 4K 31.5 Surgical Display2024-01-23Surgical Display for Operating Room
00860008848925 - VoirElite 4K 31.5 Surgical Display2024-01-23 Surgical Display for Operating Room
00860008848901 - ORION RACK2022-09-28 Video Integration Control System
00860008848918 - SKYTRON ASCEND IP2022-09-28 Video Integration Control System

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